ML28305: Analysis of the Kinetics and Effects of Vemurafenib on Intratumoral and Host Immunity in Patients with Advanced BRAF V600 Mutant Melanoma.
The purpose of this study is to assess immunologic changes in the metastatic melanoma microenvironment of patients with BRAFV600E mutant melanoma treated with vemurafenib.
The NEMO trial-A randomized Phase III, open label, multicenter, two-arm study comparing the efficacy of MEK162 versus Dacarbazine in patients with previously untreated advanced unresectable or metastatic NRAS mutation-positive melanoma
This study is for patients with untreated advanced unresectable or metastatic melanoma harboring NRAS mutation (i.e. a very specific type of advanced skin cancer). This study is being done to find out if the drug MEK162 is safe and to learn about the effects (good and bad) in people with advanced unresectable or metastatic melanoma compared with the common treatment, Darcarzabine.
Patients will be seen every 3 weeks until treatment is stopped. Patients will be randomized to one of the treatment arms and will compelte questionnaires periodically during the study. There is a biomarker component to the study and an optional consent for future research. Patients will be followed for survival until the study ends.
A Randomized Phase II Trial of Vemurafenib (PLX4032/RG7204) with or without Bevacizumab in Patients with Stage IV BRAFV600 Mutant Melanoma.
The purpose of this study is to compare the efficacy and safety of vemurafenib versus the combination of vemurafenib and bevacizumab in patients with Stage IV BRAFV600 mutant melanoma.
Expanded Access Program with Nivolumab (BMS-936558) in Combination with Ipilimumab (Yervoy) in Anti-CLTA-4 Treatment-Naïve Subjects with Unresectable or Metastatic Melanoma(CA209218 )
Description: This is an Expanded Access Program (EAP) Treatment Use Protocol of nivolumab combined with ipilimumab in adult patients who have unresectable or metastatic melanoma. Subjects must have stage III (unresectable) or stage IV melanoma and must not have received prior anti-CTLA-4 therapy for the treatment of unresectable or metastatic melanoma. Participants will receive nivolumab (BMS-936558) administered IV over 60 minutes at 1 mg/kg combined with ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Part I) then continued with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks until progression or a maximum of 48 weeks, whichever comes first (Part II).
CA209204: A Multi-Center Phase 2 Open-Label Study to Evaluate Safety and Efficacy in Subjects with Melanoma Metastatic to the Brain treated with Nivolumab in Combination with Ipilimumab followed by Nivolumab Monotherapy.
The purpose of this study is to evaluate overall safety and tolerability of the combined regimen of an investigational drug nivolumab (also known as BMS-936558) in combination with ipilimumab (Yervoy™) followed by nivolumab alone (monotherapy) in patients with melanoma brain metastases.
Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body’s immune system to work against tumor cells. Ipilimumab (Yervoy™) is an approved therapy for metastatic melanoma and has demonstrated improved overall survival as monotherapy and in combination with dacarbazine. In the proposed study, the combination treatment of nivolumab and ipilimumab followed by nivolumab monotherapy in the treatment of melanoma brain metastases continues the work of exploring immune based therapies in this patient population.